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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilizer, Steam
510(k) Number K070657
Device Name GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER
Applicant
GETINGE SOURCING LLC
1777 EAST HENRIETTA RD.
ROCHESTER,  NY  14623 -3133
Applicant Contact ANN WHEELER
Correspondent
GETINGE SOURCING LLC
1777 EAST HENRIETTA RD.
ROCHESTER,  NY  14623 -3133
Correspondent Contact ANN WHEELER
Regulation Number880.6880
Classification Product Code
FLE  
Date Received03/09/2007
Decision Date 04/05/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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